Quality Partner Japan

Make your mark for patients

患者さんのためにあなたの力を発揮してください

チームについて

日本市場における品質管理を支える重要な役割を担っていますグローバルおよびローカルの関係部門品質サプライチェーン安全性薬事と密接に連携しながら製品品質及び品質システムの維持と継続的改善を推進するチームです多様なバックグラウンドを持つメンバーと協働し相互に知見を共有しながら業務を進める環境です

主な業務内容
本ポジションでは日本市場における品質管理体制の運用と改善をリードし規制遵守を確保しながら高品質なオペレーションを実現します社内外のステークホルダーと連携し品質リスクの特定と低減プロセス改善を推進していただきます
ローカル品質管理システムの運用と継続的改善の推進
品質関連業務の進捗管理と期限内完了の確保
監査や査察指摘事項への是正予防対応の実施
外部委託先やサプライヤーの品質管理および評価
製品の出荷判定およびトレーサビリティ管理の実施
品質リスクの特定と低減施策の立案実行

応募資格必須
薬剤師資格
英語ビジネスレベルグローバルとの会議で発言ディスカッションが可能な方
品質関連業務経験5年以上

あれば尚可の経験スキル
規制当局や外部組織との対応経験
部下管理経験入社後のポジションでPeople Managementは発生しません
製造または品質管理の実務経験と規制知識

求める人物像
勉強熱心な方
関係者と円滑に連携できるコミュニケーション能力
主体性を持ち自律的に業務を遂行できる方

(English follow)

JOB SUMMARY

The Quality Partner for an area or country is a local transversal role designed to:

o Act under the direction of the responsible Market Quality Lead
o When applicable act as the primary quality contact for the Japan Affiliate. Manage the Affiliate Market Quality activities.
o When applicable direct oversight to Affiliate quality personnel.
o Exhibit a culture of collaboration and continuous improvement emphasizing oversight to implementation and compliance to UCB quality standards policies procedures including compliance of cGxP regulation(s) imposed on controlled or un-licensed medicinal products by national laws or applicable regulatory authorities.
o Operational management of the local Quality Management System.
o Assist in the identification and mitigation of quality issues and risks highlight improvement opportunities and facilitate the development of solutions.
o Work with stakeholders (e.g. Affiliate Management Market Quality Global Quality Supply Chain Pharmacovigilance Regulatory) organizations to facilitate support for the local Quality organization and ensure GxP operations deliverables are achieved in a timely manner.
o Act as the Responsible Person (RP) in charge of the market release duties (市場出荷判定者) for UCB Japan according to GQP ordinance.

MAJOR RESPONSIBILITIES

Quality Partner is responsible to:

Ensure execution of the local Quality Management System.
o Ensure all applicable Quality deliverables are effectively monitored managed and completed in a timely manner in accordance with Global SOPs.
o Address any deficiencies identified through audits and inspections by providing guidance for identification and timely implementation of appropriate corrective and preventive actions.
o Maintain the Quality Manual.
o Execution of responsibilities related to Management Reviews to confirm consistency and compliance with UCB procedures and local regulations and to highlight adverse trends to management.
o Participation in periodic Product Quality Review in accordance with the MAH responsibility when required.
o Establish and/or provide support to execute internal self-inspection and audit programs when required
o Support readiness and participation for all applicable cGxP external audits and regulatory inspections of UCB
o When required provide Quality oversight to Local GxP Vendors in compliance with UCB Quality procedures including qualification quality agreements monitoring through audit and/or periodic assessment and divestment or discontinuation. Approving any subcontracted activities impacting GDP or GMP at the Affiliate. As applicable ensure suppliers and customers of the Affiliate are qualified.
o When required collaborate with key GxP and business stakeholders to identify and assess quality risks and support the local risk champion in risk mitigation activities. Together with site management provide direction formulate strategies and make decisions which ensure efficient Quality operations and Quality risk mitigation.
o Ensure product traceability as required. Implement and/or execute compliant batch management and disposition processes including management of returned rejected recalled or falsified products and authorization of return to saleable stock for any returned medicinal products.
o When required participate in local recalls and all related correspondence with national competent authorities and participate in Global recall activities when required
o Ensure compliance to GMP/GDP (GMP as appicable for Affiliates having GMP activities/license) and ensure proper shipping conditions are implemented as applicable driving a QA decision on the disposition of the product in case of deviations (including excursions).

EDUCATION & QUALIFICATION

Education Level: Bachelors Degree

Other Certification :

• Pharmacist
• Minimum of 5 years working in the pharmaceutical industry in a quality management and/or Qualified Person position having operational GMP experience.
• Experience interacting with regulatory bodies or third-party organizations with respect to Quality systems and regulatory inspection preparedness would be an advantage.
• Staff Management would be an advantage.

患者さんのために価値を創造しご自身の力を発揮する準備ができているとお感じでしたらぜひ私たちにご連絡ください

会社概要

UCBは神経および免疫領域に注力するグローバルなバイオ医薬品企業です世界中で約8500人の社員が患者さんからインスピレーションを受け科学の力で前進しています

UCBで働く魅力

UCBでは単に業務をこなすのではなく価値を創造することを大切にしています私たちは挑戦を恐れず協力し合い革新を追求しながら患者さんのために成果を出すことを目指しています
誰もが尊重され受け入れられ最善を尽くせる平等な機会がある思いやりと支援に満ちた文化が根付いています
私たちは常にその先を目指し患者さん社員そして地球に対して人間らしさを大切にした価値を提供しています
UCBで働くことで自分自身の成長を実感し自由にキャリアを築き可能性を最大限に引き出すことができます

UCBでは機会均等を重視していますすべての採用決定は法律で保護されているいかなる属性にも関係なく行われます

選考プロセスにおいてご自身の強みや能力を十分に発揮できるよう配慮が必要な場合は以下のメールアドレスまでご連絡ください

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